(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations
Masqué
XU Yuan
(a) the reporting obligations: Reporting of serious incidents and field safety corrective actions, Trend reporting, Analysis of serious incidents and field safety corrective actions, Analysis of vigilance data, Implementing acts
(b) in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV is issued.